Amiodarone hydrochloride is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride and have the following structural formula

Amiodarone is a class III antiarrhythmic drug. Approved products include tablets (oral) as well as injectable injections. Two injectable dosage forms approved in the United States include—CORDARONE® and NEXTERONE®. These are indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.
CORDARONE® is an injection solution concentrate of Amiodarone, having 50 mg/ml Amiodarone hydrochloride. Each mL of the amiodarone I.V. formulation contains 50 mg of amiodarone hydrochloride, 20.2 mg of benzyl alcohol, 100 mg of polysorbate 80, and water for injection.
NEXTERONE® Premixed Injection is available as a diluted, nonpyrogenic, iso-osmotic solution for intravenous administration, each mL containing 1.5 mg of amiodarone HCl, USP; 15 mg of betadex sulfobutyl ether Sodium (a cyclodextrin), 0.362 mg of citric acid anhydrous, 0.183 mg of sodium citrate dihydrate and 42.1 mg dextrose anhydrous in water for injection.
Surprisingly, the inventors of the present invention found out a ready-to-administer parenteral dosage form of amiodarone, which does not make use of any solubilizers such as surfactant, for example polysorbate 80 and complexing agents like cyclodextrins, but yet provides a stable, clear aqueous solution of amiodarone. Further, this aqueous solution, more importantly, when stored in plastic containers do not show any signs of sorption to the containers.